GPT and Cholecystitis: In the BAC arm, severe TEAEs included alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation and hypertension (6.3% each) as well as nausea, vomiting, leukopenia, abdominal pain, and upper abdominal pain (3.1% each); and SAEs included cholecystitis, nausea and vomiting (6.3% each).